The Role of Adjuvant Albendazole After Pulmonary Hydatid Cyst Resection

Not Applicable

Recruiting

• Conditions: Pulmonary Hydatid Cyst
• Interventions: Drug: Albendazole; Drug: Placebo

• Registration Number: NCT06483880
• Lead Sponsor: Ain Shams University

Brief Summary

The aim of this study is to study the role of adjuvant Albendazole after pulmonary hydatid cyst resection versus placebo in reducing recurrence with a short- term follow-up of six months.

Detailed Description

Hydatid disease, also referred to as cystic echinococcosis, is a major zoonotic disease with global distribution caused by the larval stage of the Echinococcus parasite, which belongs to the Taeniidae family and Echinococcus genus.

Cystic Echinococcosis is prevalent in several regions across the globe, including Mediterranean countries, southern America, Australia, eastern and northern Africa, as well as the Tibetan terrain of Asia.

Dogs and other members of the canid family serve as definitive hosts, as they harbor adult tapeworms within their intestinal tract and excrete parasite eggs in their feces. The intermediate hosts, which encompass a wide range of mammalian species including humans, can get accidentally infected through the ingestion of eggs via food or water that has been contaminated. Upon ingestion of tapeworm eggs found in the feces of dogs, the embryos are liberated from the eggs, traverse the intestinal mucosa, and disseminate to various organs via the bloodstream. The liver accounting for 60% to 70% of infections, and the lungs, comprising around 20% to 30% of infected cases, are the organs most frequently affected by infection.

Surgery is the gold standard treatment to get rid of a pulmonary hydatid cyst, though in some rare cases chemotherapy may be necessary. Despite claims that very small cysts can disappear on their own, surgery remains the gold standard for treating hydatid cysts. Re-surgery after recurrence is associated with increased operative morbidity and mortality. Surgical intervention may sometimes be required due to the development of complications in patients who receive only medical treatment.

Mebendazole was initially used for the therapeutic treatment of the hydatid cyst. Nevertheless, the drug's uptake from the gastrointestinal tract was poor, prompting its substitution with albendazole, which has better absorption. The drug's activity is enhanced by its metabolite, albendazole sulfoxide, which readily diffuses through the cyst membrane and accumulates in the cyst fluid. It has been shown that adjuvant albendazole treatment is effective in reducing recurrence postoperatively in liver hydatidosis.

The standard care in Ain Shams University Hospitals regarding prescription of albendazole after surgery is surgeon's preference. To the best of our knowledge, there was a gap of knowledge regarding the role of adjuvant Albendazole after pulmonary hydatid cyst resection. So, we will conduct this study.

Study Timeline

• Status Verified: 2024-02
• Study Start: 2024-02-01
• Study First Submitted: 2024-06-23
• Study First Submitted QC: 2024-06-28
• Study First Posted: 2024-07-03
• Last Update Submitted: 2025-02-14
• Last Update Posted: 2025-02-17
• Primary Completion: 2025-06-01
• Study Completion: 2025-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

1. All patients regardless of age with pulmonary hydatid disease requiring surgical resection.
2. Patients achieving complete resection of pulmonary hydatid disease.
3. Patients with no extra pulmonary hydatid disease.
4. Patients who have received preoperative albendazole.

Exclusion Criteria

1. Patients with extra pulmonary hydatid disease requiring treatment after pulmonary resection.
2. Patients with incomplete resection of pulmonary hydatid disease.
3. Patients with pulmonary hydatid disease not amenable for resection.
4. Patients with hypersensitivity to Albendazole.
5. Patients with liver dysfunction.
6. Patients refusing to be enrolled in the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Albendazole arm	Albendazole	The administration of albendazole therapy is recommended at a dosage of 15 mg/kg/day, given in two equally split doses per day. This is within two 15-day cycles following surgery.
Placebo arm	Placebo	Patients will receive the placebo, which will be in two equally split doses per day. This is within two 15-day cycles following surgery.

Primary Outcome Measures

Name	Time	Method
Recurrence of pulmonary hydatid disease	six months	Recurrence of pulmonary hydatid disease in six months in both groups, assessed by: 1. Chest X-ray radiography after the 2 weeks.; 2. CT chest in six months and after one year or symptoms requiring CT chest at any timing.

Secondary Outcome Measures

Name	Time	Method
Financial cost between both groups.	Six months
In hospital mortality between both groups.	Six months
Liver function tests (AST and ALT) between both groups.	Six months	AST and ALT will be measured in U/L before operation and after completing the two 15-day cycles of Albendazole or Placebo in either group. And after six months in both groups.
Length of hospital stay between both groups.	Six months

Trial Locations

Locations (1)

Ain Shams University Hospitals; 🇪🇬 Cairo, Al Abbasiya, Egypt